Conductive Hearing LossNCT03541967
Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband
A study testing ADHEAR and PONTO 3 SUPER POWER on softband hearing aids in people with Conductive Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH.
Trial summary
Main objectives The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Conductive Hearing Loss
- What is being tested?
- ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2018to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: between 5 and 15 years old.
- Child for whom a bone conduction prosthesis test is indicated
- conductive hearing loss: bone conduction ≤ 10 dB Hearing Level (HL)
- Contralateral ear: air conduction ≤ 30 dB HL at 500, 1000, 2000, 3000 and 4000Hz
- No test of conductive bone conduction hearing aid with softband in the 3 months preceding the study
- No associated disorders
- Child not already fitted with a bone conduction system
Who cannot join
None listed.
About this study
Official title: Study of the Hearing Performance and Comfort of a New Bone Conduction Hearing System - Comparison to the Osteo-integrated Bone Conduction Hearing Aid Mounted on a Headband: Prospective Open Multicenter Randomized Crossover Study
Main objectives
- The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.
Secondary objectives
- Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate the satisfaction and use of ADHEAR.
Read the detailed description
Introduction
Hearing loss, or deafness, is defined by the decrease in the perception of sounds. Conductive hearing loss is characterized by damage to the outer or middle ear. Its etiologies are congenital, malformative or acquired, sequelae of infectious or inflammatory processes (chronic otitis).
They cause a defect in the transmission of the sound towards the cochlea. Conductive hearing loss can be compensated by bone conduction hearing aids or middle ear implants.
Osteo-integrated bone conduction hearing aids (Baha, Ponto) have become the standard of care for patients with conductive hearing loss when an acoustic hearing aid can't be used.
These prostheses are percutaneous but for children the implantation of the osseointegrated abutment requires that the child has developed a sufficient bone thickness. In general, surgery is not possible before the age of 5 years. [Doshi et al. 2012].
They can be mounted on headband for testing [Haute Autorité de Santé, HAS 2008] or avoid surgery especially for very young children [e.g. Hol et al. 2005, Verhagen et al. 2008, Doshi et al. 2012, Doshi and McDermott 2015]. In this case the vibration of the bone is through the skin. But these systems on headband pose problems of maintenance and pressure on the skin.
Standard headband pre-tests are recommended by HAS [HAS 2014] and the bone anchored hearing aid is a gold standard for preoperative evaluation in children. It can be used to predict the potential benefit of the implanted system [Doshi et al. 2012]. Several transcutaneous systems are developed today [Reinfelt 2015, Doshi et al. 2012, Doshi and McDermott 2015] but they also require surgery and have an age limit before implantation.
MED-EL company has developed a new bone conduction system, ADHEAR, that does not require surgery and that transmits the sound by bone vibration through the skin. This system has the advantage of not applying pressure on the skin and has no age limit.
Objective of the study:
The objective of the study is to compare the new ADHEAR bone conduction hearing aid for children with conductive hearing loss to the commonly used reference system, the osteointegrated bone conduction prosthesis.
Comparator:
The comparator is the same in all the centers and will be the PONTO 3 SUPER POWER mounted on softband.
Hypotheses
The hypotheses are that patients with the ADHEAR bone conduction hearing aid:
- do not have a mean tonal gain lower than that obtained with a PONTO 3 SUPERPOWER mounted on a softband.
- have a gain in comfort compared to a PONTO 3 SUPERPOWER mounted on a sofband
Main objectives
- The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.
Secondary objectives
- Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
- To evaluate the satisfaction and use of ADHEAR.
Plan of study
It is a prospective open multicenter randomized crossover study: measures will be done on the patient at the inclusion then by randomisation a first system (ADHEAR or PONTO 3 SUPER POWER on softband) will be fit to the patient and he will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the first system. Then the patient will be fitted with the second system (PONTO 3 SUPER POWER on softband or ADHEAR) and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the second system.
- Conditions
- Conductive Hearing Loss
- Being tested
- ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
- Keywords
- bone conduction
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHEAR and PONTO 3 SUPER POWER on softband hearing aidsDevice
Device: ADHEAR non-implantable bone conduction hearing aid Comparator: PONTO 3 SUPER POWER bone conduction hearing aid with softband
| Study group | Role | What they receive |
|---|---|---|
| ADHEAR-PONTO | Other | The ADHEAR system will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. Then the patient will be fitted with the PONTO 3 SUPER POWER on softband and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband. Receives: Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids |
| PONTO-ADHEAR | Other | The PONTO 3 SUPER POWER on softband will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband. Then the patient will be fitted with the ADHEAR system and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. Receives: Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average tonal gain (dB)
The threshold of free-field tonal audiometry is measured in the free field with masking of the contralateral ear with and without the auditory system. The tonal gain is defined by the difference of the tonal threshold with / without the auditory system. The average tonal gain is defined by the average of the tonal gain at frequencies 500, 1000, 2000, 3000 and 4000 Hz.
Measured: 15 days after fitting of the system and port at home
Comfort
Perceived comfort will be measured with a visual analogue scale (VAS) of 10 cm overall comfort. The VAS will have the following anchors:
10 = very comfortable; 8 = comfortable; 6 = comfortable enough; 4 = uncomfortable; 2 = very uncomfortable; 0 = not comfortable at all
Measured: 15 days after fitting of the system and port at home
Secondary outcomes (7)
Skin reactions
The measurement of cutaneous reactions with the auditory system will be done with a Holgers scale by the practitioner. Holgers scale:
0 = No irritation; 1 = Slight redness; 2 = Red and slightly moist tissue; 3= Reddish and moist; 4 = Removal of hearing aid system necessary R = Removal of hearing aid system for reasons not related to skin problems
Measured: 15 days after fitting of the system and port at home
Bone conduction thresholds (dB Hearing Level (HL))
The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000 and 4000 Hz. The variation is defined by the difference of bone conduction threshold at each frequency at the inclusion and at the end of the inclusion.
Measured: at the inclusion and 30 days after
Subjective measurement of auditory perception
The subjective auditory perception will be measured by a self-questionnaire to be completed by the parents: the Speech, Spatial, and Qualities of Hearing Scale (SSQ) for Parents [Galvin and Noble 2013]. The parents have to answer questions about specific situations for their child with and without the hearing system.
SSQ items have VAS from 0 to 10 with integer anchors and qualitative anchors "not at all" for 0 and "perfectly" for 10.
Scores are calculated for three subscales:
- on speech perception: 9 VAS
- on spatial localization: 6 VAS
- on the quality of hearing: 8 VAS
On each subscale the difference of score with and without the hearing system is calculated.
Measured: 15 days after fitting of the system and port at home
Measurement of satisfaction and use of ADHEAR
The satisfaction and use of ADHEAR will be measured by a specific MED-EL self-questionnaire. Twenty questions with various qualitative answers. The analysis is descriptive for each question.
Measured: 15 days after fitting of the system and port at home
Air conduction threshold (dB HL)
The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000, 4000 and 8000 Hz. The variation is defined by the difference of air conduction threshold at each frequency at the inclusion and at the end of the inclusion.
Measured: at the inclusion and 30 days after
Vocal audiometry in silence
Measure of the speech reception threshold (i.e. the speech intensity in dB Sound Pressure Level (SPL)) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field (with masking of the contralateral ear) with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.
Measured: 15 days after fitting of the system and port at home
Vocal audiometry in noise
Hirsch test in dichotic condition: signal = speech words (list of Boorsma) on the side of the auditory system ; noise = white noise at 65 dB Sound Pressure Level (SPL) in front of the patient (0°). Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.
Measured: 15 days after fitting of the system and port at home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start15 Jul 2018 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Why it stopped: overload costs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541967
- Sponsor's protocol ID
- MED-EL_ADHEAR_french_study1
- Status last verified
- Jun 2019
- First submitted
- 4 May 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Hearing Performance and Comfort of a New Bone Conduction Hearing System - Comparison to the Osteo-integrated Bone Conduction Hearing Aid Mounted on a Headband: Prospective Open Multicenter Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03541967
- Acronym / sponsor ID
- MED-EL_ADHEAR_french_study1
- Conditions
- Conductive Hearing Loss
- Keywords
- bone conduction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: overload costs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2018 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main objectives
- The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.
Secondary objectives
- Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate the satisfaction and use of ADHEAR.
Detailed description
Introduction
Hearing loss, or deafness, is defined by the decrease in the perception of sounds. Conductive hearing loss is characterized by damage to the outer or middle ear. Its etiologies are congenital, malformative or acquired, sequelae of infectious or inflammatory processes (chronic otitis).
They cause a defect in the transmission of the sound towards the cochlea. Conductive hearing loss can be compensated by bone conduction hearing aids or middle ear implants.
Osteo-integrated bone conduction hearing aids (Baha, Ponto) have become the standard of care for patients with conductive hearing loss when an acoustic hearing aid can't be used.
These prostheses are percutaneous but for children the implantation of the osseointegrated abutment requires that the child has developed a sufficient bone thickness. In general, surgery is not possible before the age of 5 years. [Doshi et al. 2012].
They can be mounted on headband for testing [Haute Autorité de Santé, HAS 2008] or avoid surgery especially for very young children [e.g. Hol et al. 2005, Verhagen et al. 2008, Doshi et al. 2012, Doshi and McDermott 2015]. In this case the vibration of the bone is through the skin. But these systems on headband pose problems of maintenance and pressure on the skin.
Standard headband pre-tests are recommended by HAS [HAS 2014] and the bone anchored hearing aid is a gold standard for preoperative evaluation in children. It can be used to predict the potential benefit of the implanted system [Doshi et al. 2012]. Several transcutaneous systems are developed today [Reinfelt 2015, Doshi et al. 2012, Doshi and McDermott 2015] but they also require surgery and have an age limit before implantation.
MED-EL company has developed a new bone conduction system, ADHEAR, that does not require surgery and that transmits the sound by bone vibration through the skin. This system has the advantage of not applying pressure on the skin and has no age limit.
Objective of the study:
The objective of the study is to compare the new ADHEAR bone conduction hearing aid for children with conductive hearing loss to the commonly used reference system, the osteointegrated bone conduction prosthesis.
Comparator:
The comparator is the same in all the centers and will be the PONTO 3 SUPER POWER mounted on softband.
Hypotheses
The hypotheses are that patients with the ADHEAR bone conduction hearing aid:
- do not have a mean tonal gain lower than that obtained with a PONTO 3 SUPERPOWER mounted on a softband.
- have a gain in comfort compared to a PONTO 3 SUPERPOWER mounted on a sofband
Main objectives
- The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
- The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.
Secondary objectives
- Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
- Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
- To evaluate the satisfaction and use of ADHEAR.
Plan of study
It is a prospective open multicenter randomized crossover study: measures will be done on the patient at the inclusion then by randomisation a first system (ADHEAR or PONTO 3 SUPER POWER on softband) will be fit to the patient and he will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the first system. Then the patient will be fitted with the second system (PONTO 3 SUPER POWER on softband or ADHEAR) and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the second system.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHEAR-PONTO | Other | Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aidsThe ADHEAR system will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. Then the patient will be fitted with the PONTO 3 SUPER POWER on softband and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband. |
| PONTO-ADHEAR | Other | Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aidsThe PONTO 3 SUPER POWER on softband will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband. Then the patient will be fitted with the ADHEAR system and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: between 5 and 15 years old.
- Child for whom a bone conduction prosthesis test is indicated
- conductive hearing loss: bone conduction ≤ 10 dB Hearing Level (HL)
- Contralateral ear: air conduction ≤ 30 dB HL at 500, 1000, 2000, 3000 and 4000Hz
- No test of conductive bone conduction hearing aid with softband in the 3 months preceding the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHEAR and PONTO 3 SUPER POWER on softband hearing aidsDevice: ADHEAR non-implantable bone conduction hearing aid Comparator: PONTO 3 SUPER POWER bone conduction hearing aid with softband | Device | ADHEAR-PONTO, PONTO-ADHEAR |
Primary outcome
Average tonal gain (dB)
Time frame: 15 days after fitting of the system and port at home
The threshold of free-field tonal audiometry is measured in the free field with masking of the contralateral ear with and without the auditory system. The tonal gain is defined by the difference of the tonal threshold with / without the auditory system. The average tonal gain is defined by the average of the tonal gain at frequencies 500, 1000, 2000, 3000 and 4000 Hz.
Comfort
Time frame: 15 days after fitting of the system and port at home
Perceived comfort will be measured with a visual analogue scale (VAS) of 10 cm overall comfort. The VAS will have the following anchors: 10 = very comfortable; 8 = comfortable; 6 = comfortable enough; 4 = uncomfortable; 2 = very uncomfortable; 0 = not comfortable at all
7 secondary outcomes
Skin reactions
Time frame: 15 days after fitting of the system and port at home
Bone conduction thresholds (dB Hearing Level (HL))
Time frame: at the inclusion and 30 days after
Subjective measurement of auditory perception
Time frame: 15 days after fitting of the system and port at home
Measurement of satisfaction and use of ADHEAR
Time frame: 15 days after fitting of the system and port at home
Air conduction threshold (dB HL)
Time frame: at the inclusion and 30 days after
Vocal audiometry in silence
Time frame: 15 days after fitting of the system and port at home
Vocal audiometry in noise
Time frame: 15 days after fitting of the system and port at home
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ADHEAR and PONTO 3 SUPER POWER on softband hearing aids in people with Conductive Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average tonal gain (dB) (time frame: 15 days after fitting of the system and port at home). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.